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Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat and Maxilla-Facial Surgery

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ClinicalTrials.gov Identifier: NCT02968823
Recruitment Status : Not yet recruiting
First Posted : November 21, 2016
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Olga Plattner, Medical University of Vienna

Brief Summary:
Our primary aim is to determine whether licorice gargling provides meaningful analgesia after oral surgery. Specifically, we propose to test the primary hypothesis that gargling with licorice solution reduces pain after oral surgery more than gargling with sugar water. Because effective analgesia can reduce pain and/or opioid consumption, we will jointly evaluate verbal response pain scores and overall morphine consumption considering licorice to be beneficial only if it proves non-inferior on both measures and superior on at least one.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Surgery, Oral Other: Licorice Other: Sugar water Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat (ENT) and Maxilla-Facial Surgery - A Randomized, Double-blind Study
Study Start Date : November 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Active Comparator: Licorice
Licorice gargle
Other: Licorice
ExtractumLiquiritiaeFluidum, 1 g diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 2
Other Name: Extractum Liquiritiae Fluidum

Placebo Comparator: Sugar water
Sugar gargle
Other: Sugar water
Sugar gargle: Sirupus Simplex (sugar 5 g) diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 2




Primary Outcome Measures :
  1. joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU) [ Time Frame: first 2 postoperative hours ]
    A joint outcome of average pain score and total opioid consumption between the end of surgery and the first two postoperative hours. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.


Secondary Outcome Measures :
  1. joint - pain scores and opiate consumption on day of surgery [ Time Frame: from end of surgery until the morning of Post-Operative Day (POD) 1 ]
    Postoperative pain intensity and opioid consumption between the end of surgery and the first postoperative morning. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.

  2. joint - pain scores and analgesic consumption [ Time Frame: from surgery conclusion to Post-Operative Day (POD) 3 ]
    pain intensity and total analgesics (metamizole or mefenamic acid) consumption in the first three days after surgery. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two.

  3. postoperative coughing [ Time Frame: first 2 postoperative hours ]
    incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU



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Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Oropharyngeal surgeries including:Panendoscopic surgery; elective tonsillectomy/adenotonsillectomy; demarcation and biopsy of suspected tongue carcinoma
  2. Anticipated extubation in the operating room
  3. American Society of Anesthesia physical status 1-3

Exclusion Criteria:

  1. Rapid Sequence Induction
  2. Known or suspected allergy to licorice or its ingredients
  3. Liver failure with bleeding disorders
  4. Insulin-dependent diabetes mellitus
  5. Use of non-steroidal anti-inflammatory drug medication within 24 hours before surgery
  6. Chronic opioid use
  7. Dementia or inability to use an iv Patient-Controlled-Analgesia (PCA) pump
  8. superinfected oropharyngeal tumors
  9. Planned postoperative mechanical ventilation or admission to Intensive Care Unit (ICU)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968823


Contacts
Contact: Olga Plattner, M.D. 0043-1-40400-0 olga.plattner@meduniwien.ac.at
Contact: Marita Windpassinger, M.D. 0043-1-40400-0 marita.windpassinger@meduniwien.ac.at

Sponsors and Collaborators
Medical University of Vienna
The Cleveland Clinic
Investigators
Study Chair: Olga Plattner, M.D. Medical University of Vienna
Principal Investigator: Marita Windpassinger, M.D. Medical University Vienna

Responsible Party: Olga Plattner, Ao. Univ. Prof., Head of ophthalmologic anesthesia, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02968823     History of Changes
Other Study ID Numbers: 1308/2016
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Olga Plattner, Medical University of Vienna:
Postoperative Pain
Anesthesia
Oral Surgery

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms